Universal reference book for medicines
Product name: DAKARBAZIN LACHEMA (DACARBAZIN LACHEMA)

Active substance: dacarbazine

Type: Antitumor preparation

Manufacturer: PLIVA-LACHEMA (Czech Republic)
Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intravenous administration of
white or light yellow color.

1 f.

dacarbazine 100 mg

Excipients: citric acid, mannitol.

Vials of dark glass (1) - packs of cardboard.

Bottles of dark glass (10) - packs of cardboard.

Lyophilizate for the preparation of a solution for intravenous administration of white or light yellow color.

1 f.

dacarbazine 200 mg

Excipients: citric acid, mannitol.

Vials of dark glass (1) - packs of cardboard.

Bottles of dark glass (10) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Dakarbazine is an anticancer agent of an alkylating effect, in chemical composition it is 5- (3,3-dimethyl-1-triazene) -imidazole-4-carboxamide.

The drug becomes active after metabolism in the liver, releasing diazomethane.

It is assumed that there are three ways of the mechanism of dacarbazine: alkylation due to carbonium ions, oppression of purine bases and interaction with SH-groups.
The preparation is phase-specific.
PHARMACOKINETICS

C max in plasma is usually achieved immediately after intravenous administration of the drug.
The connection with plasma proteins is about 5%. Penetrates through the blood-brain barrier in small amounts. There is no evidence of its penetration into the placenta and breast milk.
The drug is withdrawn from the body biphasic with an initial T 1/2 of about 20 minutes and the final - about 5 hours, with violations of the liver or kidneys, these indicators are approximately 55 min and 7 h respectively.

The drug is dimethylated with hepatic microsomal enzymes with the formation of carbon dioxide, which is excreted with exhaled air and aminoimidazolecarboxamide, which is excreted in the urine.
40% of the drug is excreted by the kidneys unchanged, mainly due to glomerular filtration.
INDICATIONS

- melanoma;

- lymphogranulomatosis;

- soft tissue sarcoma (excluding Kaposi's sarcoma).

There are reports of the effectiveness of dacarbazine in combination with other cytostatics in the treatment of osteogenic sarcoma, sarcoma of the uterus, pleural mesothelioma and peritoneum, small cell lung cancer, thyroid cancer, carcinoid, pheochromocytoma, insulinoma, neuroblastoma and glioma.

DOSING MODE

The drug is administered only in / in.
Doses and mode of administration of the drug are selected individually.
Doses up to 200 mg / m 2 are injected slowly slowly for 1-2 minutes.
Higher doses should be administered in the form of IV infusions for 15-30 minutes.
Usually, as a monotherapy, dacarbazine is used at a dose of 200-250 mg / m 2 daily for 5 days;
it is also possible to administer the drug once in a dose of 850 mg / m 2instead of the 5-day course. Repeated courses are held at intervals of 3 weeks.
When combined with other cytostatics, dacarbazine is administered at a dose of 100-150 mg / m 2 for 4-5 consecutive days with an interval of 4 weeks or at a dose of 375 mg / m 2 every 15 days.

Before administration, the drug is diluted with water for injection to reach a concentration of 10 mg / ml.
To obtain a solution for infusion, a freshly prepared solution is diluted in 200-300 ml of 0.9% sodium chloride solution or 5% dextrose solution.
A solution of dacarbazine should be protected from light.

If the liver and / or kidney function is impaired, a dose reduction may be required.

SIDE EFFECT

Side effects are classified by frequency: very often (? 1/10);
often (? 1/100, <1/10); infrequently (? 1/1 000, <1/100); rarely (? 1/10 000, <1/1 000); very rarely (<1/10 000).
On the part of the organs of hematopoiesis: often - anemia, leukopenia, granulocytopenia, thrombocytopenia.
Oppression of myelopoiesis is a limiting dose, a side effect. Leukocytopenia is usually observed on day 14, thrombocytopenia - on day 18 after the end of therapy and lasts an average of 1 week. Recovery of blood counts occurs by the 4th week.
On the part of the digestive system: often - nausea, vomiting, decreased appetite, stomatitis;
rarely diarrhea, increased activity of hepatic enzymes; very rarely - hepatonecrosis caused by occlusion of intrahepatic veins, possibly with a lethal outcome (as a rule, the syndrome was noted during the second course of treatment).Among his symptoms include fever, eosinophilia, abdominal pain, enlargement of the liver and shock, the severity of which rapidly builds up over several hours or days.
From the urinary system: infrequently - an increase in the content of creatine and urea in the urine.

From the side of the nervous system: infrequently - headache, visual impairment, confusion, pronounced drowsiness, convulsions, asthenic syndrome, paresthesia, facial hypodesa.

From the side of the reproductive system: often - amenorrhea, azoospermia.

Allergic reactions;
very rarely - skin rash, hyperemia of the facial skin, febrile syndrome, anaphylactic reactions.
From the skin and skin: rarely - alopecia, hyperpigmentation and photosensitization of the skin.

Local reactions: infrequent - soreness at the site of injection and along the vein;
rarely - if the product gets under the skin - severe pain, necrosis of surrounding tissues.
Other: infrequently - influenza-like syndrome, attachment of secondary infections, thrombosis of hepatic veins, myalgia;
with prolonged use increases the risk of developing neoplasms.
CONTRAINDICATIONS

- severe oppression of bone marrow hematopoiesis;

severe hepatic or renal insufficiency;

- pregnancy and the period of breastfeeding;

- hypersensitivity to dacarbazine or to any of the auxiliary components of the drug.

With caution: with myelosuppression (including on the background of concomitant radiation and chemotherapy), acute infectious diseases of the viral (including chicken pox, shingles), fungal or bacterial nature (risk of serious complications and generalization of the process), concomitant radiation therapy.

PREGNANCY AND LACTATION

Contraindication: pregnancy and the period of breastfeeding.

APPLICATION FOR FUNCTIONS OF THE LIVER

If the kidney function is impaired , a dose reduction may be required.

Contraindications: severe renal failure



APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

If the liver function is impaired , a dose reduction may be required.

Contraindications: severe hepatic impairment



SPECIAL INSTRUCTIONS

Dakarbazine should be used under the supervision of a doctor who has experience with antitumor drugs.

During the period of treatment and after it, control of the picture of peripheral blood, kidney function, liver function and its size is necessary.

If there are violations of the function of the liver or kidneys, symptoms of hypersensitivity to the drug or thrombosis of hepatic veins, dacarbazine treatment should be stopped immediately.

When the first signs of extravasation of dacarbazine (burning or soreness at the injection site), the introduction should be immediately stopped.
The remaining dose should be injected into another vein.
During treatment and within 6 months after its termination, reliable methods of contraception should be used.

During the treatment with dacarbazine, vaccination with vaccines containing live pathogens can not be performed.

Impact on the ability to drive vehicles and manage mechanisms

In the event of such adverse reactions from the nervous system, like confusion, headache, drowsiness, convulsions, one should refrain from driving and other activities requiring increased concentration of attention.

OVERDOSE

Symptoms: increased oppression of bone marrow hematopoiesis and severity of dyspepsia.

Treatment: a symptomatic, specific antidote is unknown.

DRUG INTERACTION

Drugs that induce microsomal enzymes of the liver (barbiturates, rifampicin, phenytoin) with simultaneous application can enhance the metabolism of dacarbazine.

The use of dacarbazine in combination with mercaptopurine, azathioprine and allopurinol increases the effect of the latter and increases their toxicity.

Dacarbazine can enhance the photosensitizing effect of methoxypsoralen.

The solution of dacarbazine is chemically incompatible with heparin, hydrocortisone, cysteine ​​and sodium hydrocarbonate.

Compatible with other antitumor drugs (bleomycin, cisplatin, 5-fluorouracil, vincristine, etc.) and prednisolone.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Store at a temperature of no higher than 25 ° C, in a place protected from light.
The prepared solution should be stored at a temperature not exceeding 25 ° C in the dark place for not more than 8 hours; at a temperature of 5 ° C in a protected place from light not more than 24 hours. Keep out of the reach of children!
Shelf life - 3 years.
Do not use after the expiration date printed on the package.
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